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Colitis clinical trials

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NCT ID: NCT05177835 Active, not recruiting - Ulcerative Colitis Clinical Trials

Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Start date: December 3, 2021
Phase: Phase 2
Study type: Interventional

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment. All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement. Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.

NCT ID: NCT05156125 Active, not recruiting - Colitis, Ulcerative Clinical Trials

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

NCT ID: NCT05119140 Active, not recruiting - Clinical trials for Ulcerative Colitis (Disorder)

Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis

Start date: June 10, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.

NCT ID: NCT04996797 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

ARTEMIS-UC
Start date: July 28, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis. The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive. After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.

NCT ID: NCT04989907 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland

Start date: September 8, 2021
Phase:
Study type: Observational

Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with UC or CD. In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

NCT ID: NCT04925973 Active, not recruiting - Clinical trials for Ulcerative Colitis Acute

Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management

TRIUMPH
Start date: June 1, 2021
Phase: Phase 2
Study type: Interventional

The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.

NCT ID: NCT04924114 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)

Start date: October 14, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.

NCT ID: NCT04857112 Active, not recruiting - Ulcerative Colitis Clinical Trials

Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis

Start date: September 29, 2021
Phase: Phase 2
Study type: Interventional

The study will assess the efficacy and safety of oral MT-1303 compared to placebo at 12 weeks as the induction treatment in subjects with active mild to moderate ulcerative colitis (UC), as well as maintenance treatment with open-label MT-1303 for up to 36 weeks.

NCT ID: NCT04621006 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Contact Activation System and Ulcerative Colitis

Start date: May 1, 2021
Phase:
Study type: Observational

The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis. Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.

NCT ID: NCT04607837 Active, not recruiting - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

GLADIATOR UC
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.